BKS E-Vitalize

GUDID 00822409006861

Size 1 16mm Tibial Insert PS, Vitamin E

Ortho Development Corporation

Tibial insert

• Primary Device ID: 00822409006861
• NIH Device Record Key: a08a3186-7a2f-48fb-948e-3f1df9fa73b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BKS E-Vitalize
• Version Model Number: 166-5116
• Company DUNS: 876542390
• Company Name: Ortho Development Corporation
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com

Device Dimensions

• Height: 16 Millimeter
• Height: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409006861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131337

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-31

On-Brand Devices [BKS E-Vitalize]

• 00822409032976: Size 7 20mm Tibial Insert UC
• 00822409032969: Size 7 18mm Tibial Insert UC
• 00822409032952: Size 7 16mm Tibial Insert UC
• 00822409032945: Size 7 14mm Tibial Insert UC
• 00822409032938: Size 7 13mm Tibial Insert UC
• 00822409032921: Size 7 12mm Tibial Insert UC
• 00822409032914: Size 7 11mm Tibial Insert UC
• 00822409032907: Size 7 10mm Tibial Insert UC
• 00822409032891: Size 7 9mm Tibial Insert UC
• 00822409032884: Size 7 8mm Tibial Insert UC
• 00822409032877: Size 7 7mm Tibial Insert UC
• 00822409032860: Size 6 20mm Tibial Insert UC
• 00822409032853: Size 6 18mm Tibial Insert UC
• 00822409032846: Size 6 16mm Tibial Insert UC
• 00822409032839: Size 6 14mm Tibial Insert UC
• 00822409032822: Size 6 13mm Tibial Insert UC
• 00822409032815: Size 6 12mm Tibial Insert UC
• 00822409032808: Size 6 11mm Tibial Insert UC
• 00822409032792: Size 6 10mm Tibial Insert UC
• 00822409032785: Size 6 9mm Tibial Insert UC
• 00822409032778: Size 6 8mm Tibial Insert UC
• 00822409032761: Size 6 7mm Tibial Insert UC
• 00822409032754: Size 5 20mm Tibial Insert UC
• 00822409032747: Size 5 18mm Tibial Insert UC
• 00822409032730: Size 5 16mm Tibial Insert UC
• 00822409032723: Size 5 14mm Tibial Insert UC
• 00822409032716: Size 5 13mm Tibial Insert UC
• 00822409032709: Size 5 12mm Tibial Insert UC
• 00822409032693: Size 5 11mm Tibial Insert UC
• 00822409032686: Size 5 10mm Tibial Insert UC
• 00822409032679: Size 5 9mm Tibial Insert UC
• 00822409032662: Size 5 8mm Tibial Insert UC
• 00822409032655: Size 5 7mm Tibial Insert UC
• 00822409032648: Size 4 20mm Tibial Insert UC
• 00822409032631: Size 4 18mm Tibial Insert UC
• 00822409032624: Size 4 16mm Tibial Insert UC
• 00822409032617: Size 4 14mm Tibial Insert UC
• 00822409032600: Size 4 13mm Tibial Insert UC
• 00822409032594: Size 4 12mm Tibial Insert UC
• 00822409032587: Size 4 11mm Tibial Insert UC
• 00822409032570: Size 4 10mm Tibial Insert UC
• 00822409032563: Size 4 9mm Tibial Insert UC
• 00822409032556: Size 4 8mm Tibial Insert UC
• 00822409032549: Size 4 7mm Tibial Insert UC
• 00822409032532: Size 3 20mm Tibial Insert UC
• 00822409032525: Size 3 18mm Tibial Insert UC
• 00822409032518: Size 3 16mm Tibial Insert UC
• 00822409032501: Size 3 14mm Tibial Insert UC
• 00822409032495: Size 3 13mm Tibial Insert UC
• 00822409032488: Size 3 12mm Tibial Insert UC